surgical intervention with dermapure vs native tissue in pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: comparing fda-approved dermapure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.

the investigator is comparing fda-approved dermapure with patient's own native tissue for the repair of pelvic organ prolapse. please see below for detailed objectives and endpoints for our measuring parameters: objectives specific aim #1: to determine the relative safety and efficacy of anterior and multi-compartment vaginal wall prolapse repair augmented with decellularized human dermal allograft (dermapure®) versus anterior and multi-compartment repair employing native tissue. specific aim #2: to evaluate bulge symptoms, quality of life, sexual function, and patient satisfaction our hypothesis is that pelvic organ prolapse repair augmented with dermapure® will provide superior anatomic outcomes as compared to native tissue controls with a non-inferior safety profile. endpoints safety endpoint #1: the relative proportion of allograft, native tissue, and procedure-related sae's at 12 months. safety endpoint #2: the relative proportion of allograft, native tissue, and procedure-related ae's of interest at 12 months, which include: * vaginal shortening * vaginal scarring or banding * de novo vaginal bleeding * atypical vaginal discharge * fistula formation * de novo dyspareunia * pelvic pain * peri-operative infection * vaginal infection * uti * neuromuscular disorder * sui (worsening or de novo) * uui (worsening or de novo) * difficulty emptying bladder (worsening or de novo) * graft exposure (into vagina) * graft erosion (into viscus) efficacy endpoint #1: the proportion of patients in each group at 36 months with prolapse of the target compartment beyond the hymen. efficacy endpoint #2: the proportion of patients in each group at 36 months with bulge symptoms attributable to the target compartment as determined by pfdi-20 question number 3 ("does the participant usually have a bulge or something falling out that the participant can see or feel in the vaginal area") answering "yes" and \>= 2 (responses of "somewhat", "moderately", or "quite a bit"). (barber) efficacy endpoint #3: the proportion of patients in each group at 36 months requiring re-treatment for recurrent prolapse of the target compartment (to include surgery, physical therapy or pessary insertion). efficacy endpoint #4: change in quality of life in each group from baseline to 36 months as measured by the pfdi-20 and the pfiq-7. (barber) efficacy endpoint #5: change in sexual function in each group from baseline to 36 months as measured by the pisq-ir. (rogers) efficacy endpoint #6: patient satisfaction in each group at 36 months as measured by the ssq-8. (haff) efficacy endpoint #7: patient impression in each group at 36 months of postoperative improvement by the pgi-i (srikrishna)

Eligibility criteria:
inclusion criteria: * subject is female * subject is at least 18 years of age * subject has prolapse of the anterior compartment beyond the hymen * subject reports bulge symptoms as defined in question 3 of the pfdi-20 with a response of 2 or higher ("somewhat", "moderately" or "quite a bit") * subject is willing and able to provide informed consent * subject is willing and able to comply with the follow-up protocol through 36 months exclusion criteria: * subject is pregnant or intends to become pregnant during the study * subject has untreated severe urogenital atrophy * subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (uti), or tissue necrosis * subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical) * subject has had prior pelvic radiation therapy * subject has taken systemic steroids within the last month, or immunosuppressive or immunomodulatory treatment within the last 3 months (list attached) * subject has a history of poor wound healing with or without a diagnosis of connective tissue disease * subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis * subject has uncontrolled diabetes mellitus (dm) as defined by a hemoglobin a1c \< or = to 8% (underwood, ata) * subject has a known neurologic or medical condition that may effect of currently affects bladder function * subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis) * subject is not able to conform to the modified dorsal lithotomy position * subject is currently participating in or plans to participate in another pelvic organ prolapse related study during this study * subject has had previous prolapse repair with synthetic mesh in the anterior compartment * subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue or dermapure® * subject is unable to be treated in the anterior compartment with dermapure® * subject is desirous of a concomitant hysteropexy